]>
IRCT20250420065394N1 IRCT 2025-04-28 Islamic Azad University The Effect of Selected training and Nano-Curcumin Supplementation on some Blood Factorsin Patients after Bariatric Surgery The Effect of Selected training and Nano-Curcumin Supplementation on some Blood Factorsin Patients after Bariatric Surgery 2025-05-22 anticipated 80 Complete https://irct.ir/trial/82992 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Basic scienece. 3 Patients after Bariatric Surgery. Intervention 1: Intervention Group Protocol:1. Nano-curcumin Supplementation: - Initiation: 1 month post-bariatric surgery - Product: Sina Curcumin brand - Dosage: 40 mg twice daily (with meals) - Tablet specification: Each tablet contains 40 mg nano-curcumin - Duration: 60 days2. Exercise Training: - Frequency: 3 sessions/week - Program duration: 60 days - Session components: - Warm-up - Cool-down - Resistance training - Aerobic exercise - Progressive overload: - Week 1 intensity: 50-60% of maximum heart rate (HRmax) - Final week intensity: 65-70% of HRmax - Weekly increases in both duration and intensity. Intervention 2: Intervention Group Protocol:Post-bariatric surgery patients will begin nano-curcumin supplementation (Sina Curcumin brand) at 1-month postoperative, administered as: Dosage: 40 mg twice daily (total 80 mg/day) Formulation: 40 mg tablets (one tablet per dose) Administration: With meals Duration: 60 consecutive days. Intervention 3: Exercise Protocol:The selected training program will be performed three times per week for 60 days. Each session will include warm-up, cool-down, resistance training, and aerobic exercises. Training duration and intensity will progressively increase weekly, with intensity rising from 50-60% of maximum heart rate in week 1 to 65-70% of maximum heart rate in the final week. Intervention 4: Control group: No intervention takes place. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information available.
public Mohammad Reza Goshtasbi
Unit 2, 3rd Floor, Tower No. 11, Sina Complex, Iran Zamin Street, Shahrak-e Gharb, Tehran, Iran
Tehran Iran (Islamic Republic of) 1465896460 +98 21 8809 8815 goshtasbimohammadreza@gmail.com Islamic Azad University scientific Mohammad Reza Goshtasbi
Unit 2, 3rd Floor, Tower No. 11, Sina Complex, Iran Zamin Street, Shahrak-e Gharb, Tehran, Iran
Tehran Iran (Islamic Republic of) 1465896460 +98 21 8809 8815 goshtasbimohammadreza@gmail.com Islamic Azad University Iran (Islamic Republic of) Obese men and women (BMI ≥30) Absence of medically unstable hemodynamic conditions Absence of movement disorders No underlying conditions such as advanced pulmonary/kidney diseases, liver cirrhosis, hepatitis, or gastrointestinal disorders (e.g., celiac disease, diverticulosis) No use of medications, tobacco, alcohol, or supplements Completing the PRQ form for more accurate assessment of physical health in individuals 30 years 45 years Both Individuals allergic to nano-curcumin or other plants of the Zingiberaceae family Second surgery Use of alcohol and medications (metformin, levothyroxine, cortisone, and topiramate) within 1 month prior to the study Unwillingness to continue participation in the study Absence from more than three research sessions or failure to take nano-curcumin capsules more than twice Occurrence of any health risks or complications for patients during the study protocol implementation, as confirmed by the attending physician Age Range:30-45 years E66.8 Other obesity N/A N/A Rehabilitation Diagnosis Intervention Group Protocol:1. Nano-curcumin Supplementation: - Initiation: 1 month post-bariatric surgery - Product: Sina Curcumin brand - Dosage: 40 mg twice daily (with meals) - Tablet specification: Each tablet contains 40 mg nano-curcumin - Duration: 60 days2. Exercise Training: - Frequency: 3 sessions/week - Program duration: 60 days - Session components: - Warm-up - Cool-down - Resistance training - Aerobic exercise - Progressive overload: - Week 1 intensity: 50-60% of maximum heart rate (HRmax) - Final week intensity: 65-70% of HRmax - Weekly increases in both duration and intensity Intervention Group Protocol:Post-bariatric surgery patients will begin nano-curcumin supplementation (Sina Curcumin brand) at 1-month postoperative, administered as: Dosage: 40 mg twice daily (total 80 mg/day) Formulation: 40 mg tablets (one tablet per dose) Administration: With meals Duration: 60 consecutive days Exercise Protocol:The selected training program will be performed three times per week for 60 days. Each session will include warm-up, cool-down, resistance training, and aerobic exercises. Training duration and intensity will progressively increase weekly, with intensity rising from 50-60% of maximum heart rate in week 1 to 65-70% of maximum heart rate in the final week. Control group: No intervention takes place. Low-density lipoprotein. Timepoint: Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol. Method of measurement: Measurements will be performed using standard laboratory kits. High-density lipoprotein. Timepoint: Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol. Method of measurement: Measurements will be performed using standard laboratory kits. Ferritin. Timepoint: Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol. Method of measurement: Measurements will be performed using standard laboratory kits. Albumin. Timepoint: Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol. Method of measurement: Measurements will be performed using standard laboratory kits. Hemoglobin. Timepoint: Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol. Method of measurement: Measurements will be performed using standard laboratory kits. Alanine Aminotransferase. Timepoint: Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol. Method of measurement: Measurements will be performed using standard laboratory kits. Aspartate Aminotransferase. Timepoint: Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol. Method of measurement: Measurements will be performed using standard laboratory kits. Triglyceride. Timepoint: Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol. Method of measurement: Measurements will be performed using standard laboratory kits. Body fat percentage. Timepoint: Measurements will be conducted at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol. Method of measurement: Body fat percentage will be measured using the InBody 570 device. Palatable Food Craving Questionnaire - Trait (PFQ-T). Timepoint: The questionnaire will be administered at baseline (pre-intervention) and 60 days after initiating nano-curcumin supplementation and the selected training protocol. Method of measurement: The PFQ-T questionnaire will be completed by patients before and after the research protocol, with all resulting data collected. Islamic Azad University Approved 2025-03-10 Research Ethics Committees of Islamic Azad University- East Tehran Branch Unit 2, 3rd Floor, Tower No. 11, Sina Complex, Iran Zamin Street, Shahrak-e Gharb, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)